País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
irbesartan, Quantity: 75 mg
Alphapharm Pty Ltd
Irbesartan
Tablet
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 4000
Oral
14, 7, 30, 90
(S4) Prescription Only Medicine
IRBESARTAN MYLAN is indicated for the treatment of hypertension., IRBESARTAN MYLAN is indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (> 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.
Visual Identification: A white to off-white, film-coated, round, biconvex, bevelled edge tablet debossed with "M" on one side of the tablet and "IN1" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-11-06
ABISART _Irbesartan _ PRODUCT INFORMATION NAME OF THE MEDICINE Active ingredient : Irbesartan Chemical name : 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4,4] non-1-en-4-one Structural formula : Molecular formula : C 25 H 28 N 6 O Molecular weight : 428.53 CAS Registry no. : 138402-11-6 DESCRIPTION Irbesartan is a white, to practically white, powder that is less than 0.1mg/mL soluble in water and slightly soluble in alcohol and methylene chloride. Abisart (irbesartan) is a nonpeptide angiotensin II receptor (AT 1 subtype) antagonist. It is available as 75 mg, 150 mg or 300 mg tablets for oral administration. The inactive ingredients are: povidone, lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica and OPADRY II Complete Film Coating System OY-LS-28908 White (ARTG no. 12435). PHARMACOLOGY PHARMACODYNAMICS Irbesartan is a specific antagonist of angiotensin II receptors (AT1 subtype). Angiotensin II is an important component of the renin-angiotensin system and is involved in the pathophysiology of hypertension and in sodium homeostasis. Irbesartan does not require metabolic activation for its activity. Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting effects of angiotensin II by selective antagonism of the angiotensin II (AT 1 subtype) receptors localized on vascular smooth muscle cells and in the adrenal cortex. It has no agonist activity at the AT 1 receptor and a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor (a receptor that has not been shown to be associated with cardiovascular homeostasis). Irbesartan does not inhibit enzymes involved in the renin-angiotensin system (i.e., renin, angiotensin converting enzyme [ACE]) or affect other hormone receptors or ion channels involved in the cardiovascular regulation of blood pressure and sodium homeostasis. ABISART – PRODUCT INFORMATION 2 In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose-dependent Leer el documento completo